This invention relates to methods of conducting business comprising verifying the identity and determining the concentration, potency, purity and presence of contaminants, including, but not limited to, microbial, endotoxins and particulate matter in a mixture of ingredients, and a series of integrated systems and processes for the organization, monitoring and reporting of such analyses and related metadata through an electronic network.
Pharmacies generally compound pharmaceuticals that are not readily available on the market, for example, but not limited to, specialized dosage forms, certain oncological formulations, pediatric formulations, certain ophthalmic preparations, intravenous solutions, or other compounded pharmaceuticals referred to as compounded sterile preparations (“CSPs”). In the past, the pharmacists generally followed good compounding practices mandated by federal and state pharmacy practice acts and accepted professional compounding techniques. However, these CSPs have not been subject to concentration and purity guidelines set forth by the United States Food and Drug Administration (“FDA”) or other regulatory bodies. If a compounding pharmacy wanted to analyze a product for potency or purity, it was required to engage outside testing laboratories that employed traditional analysis such as gas chromatography or other analytical procedures to test the individual CSPs. These processes are costly and time consuming and employed only on a limited basis.
It recently has been discovered that some pharmacies have failed to meet the concentration guidelines set forth by the prescribing physician, or have produced pharmaceuticals having high levels of impurities, microbial, endotoxin and particulate matter. In response, the regulatory bodies have set forth guidelines requiring that extemporaneous CSPs prepared under high-risk conditions be tested for concentration and purity prior to distribution to ensure the safety of the pharmaceutical for public use. Moreover, it is anticipated that in the future, regulatory bodies will set forth compounding guidelines for all CSPs, regardless of risk.
While the guidelines set forth by the regulatory bodies have resulted in safer and more reliable CSPs, the testing of each batch or individual CSP using traditional physical analyses has resulted in a loss of time and financial resources for the pharmacies. Therefore, there is a need for methods and systems for testing CSPs that avoid the expense and other problems associated with the use of traditional physical analyses for testing CSPs.